Contamine Sur Arve

Researchers are investigating whether transferring a "blank" culture medium into the uterus a few days before a frozen embryo transfer can improve embryo implantation and pregnancy success in women undergoing in vitro fertilization (IVF). This study focuses on patients who have experienced pregnancy failure after a previous fresh or frozen embryo transfer. The goal is to enhance immune tolerance in the uterus to improve clinical pregnancy rates without increasing multiple pregnancies. The trial compares two procedures: one group receives a "blank" culture medium transfer, where a small amount of embryo culture medium is inserted into the uterine cavity two to three days before the frozen embryo transfer. The other group undergoes a sham transfer using an empty catheter at the same timing. The study is randomized, single-blind, and conducted across multiple centers. Participants' involvement includes undergoing these transfer procedures and subsequent frozen embryo transfers. Researchers will monitor pregnancy outcomes, specifically the clinically progressive pregnancy rate at 12 weeks of amenorrhea. Participants must provide informed consent and be covered by health insurance. The study also monitors for any pregnancy failures following the embryo transfers.

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

Bronchiectasis is a chronic lung condition where parts of the bronchial tubes become permanently widened, leading to mucus buildup, infections, and ongoing inflammation. Managing this disease often includes respiratory physiotherapy to help clear mucus. However, accessing this therapy regularly can be difficult due to time, location, and availability of trained professionals. Researchers are evaluating the long-term use of the SIMEOX device, which uses brief air pressure pulses to help loosen and move mucus, combined with remote physiotherapy, to improve the quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis. The study compares two groups: one using the SIMEOX device daily at home along with remote physiotherapy sessions, and a control group receiving enhanced standard care plus remote physiotherapy. The remote physiotherapy is delivered monthly for the first three months and then every three months afterward. The study lasts on average 24 months, allowing assessment of the device's effects over the mid and long term. Participants will be monitored through quality of life questionnaires and tracking of pulmonary exacerbations during the study. Evaluations include respiratory assessments and ensuring participants can use the device and follow procedures. The main outcomes measured are changes in respiratory quality of life after six months and the annual rate of lung exacerbations over the full study period. Safety and treatment adherence will also be continuously reviewed throughout participation.

Researchers are conducting a long-term observational study to understand patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated with dupilumab as part of routine care. The study aims to gather information on patient characteristics, safety, and patient-reported outcomes over time. This study includes adults with uncontrolled COPD despite standard treatments and elevated blood eosinophil levels, reflecting real-world use of dupilumab. Participants will be followed for approximately 36 months at up to 50 sites in France. This study is non-interventional, meaning it observes patients receiving dupilumab as prescribed by their doctors without altering treatment. It collects data retrospectively and prospectively from patients newly starting dupilumab under approved guidelines for COPD. During the study, researchers will analyze various baseline and historical clinical data, including demographics, medical history, lung function, symptom patterns, exacerbations, inflammatory markers, comorbidities, and treatment history. Safety and patient-reported measures will also be assessed over the follow-up period. The study will provide detailed descriptive statistics to better characterize this patient population and the long-term outcomes of dupilumab treatment in COPD.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.

Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.

Researchers are evaluating rifabutin as a possible alternative to rifampicin for treating staphylococcal prosthetic joint infections (PJIs) managed with the DAIR strategy, which involves debridement, antibiotics, and implant retention. Rifampicin is a key antibiotic for these infections but has risks of drug interactions and liver problems. This study aims to show that rifabutin is not less effective than rifampicin and may have a better safety profile. The trial is a phase 3, multicenter, randomized, open-label, non-inferiority study focusing on these two antibiotics for staphylococcal PJIs. Participants will be randomly assigned to receive either rifabutin or rifampicin for 12 weeks alongside companion antibiotic treatments. The rifabutin group will take 2 tablets of 150 mg once daily, while the rifampicin group will take 10 mg/kg daily (600 to 1,200 mg) in one dose. Both treatments are given orally and combined with other antibiotics suitable for the infection. The study includes only patients with hip or knee PJIs caused by staphylococcal species susceptible to rifampicin and other antibiotics. During the study, participants will be monitored for treatment failure at one year. Assessments will include clinical evaluations and safety monitoring to track antibiotic tolerance and effectiveness. The trial focuses on adherence to treatment and any adverse reactions. The total participation duration includes the 12-week treatment period and follow-up to one year to measure outcomes and safety.

Researchers are evaluating the addition of a therapeutic education program combined with nursing phone follow-up compared to conventional management alone in women with non-metastatic breast cancer undergoing adjuvant hormone therapy. The study aims to reduce the impact of side effects from hormone therapy and improve patients' quality of life during the first year of treatment through personalized and coordinated care. Participants who receive the therapeutic education and nursing support program will attend an initial educational assessment around the start of their hormone therapy. They will work with a nurse to set personalized goals and choose relevant workshops as part of an outpatient educational program. This is offered alongside the usual oncology follow-up care. Throughout the first year, patients will be monitored for management of side effects related to hormone therapy. The study collects adverse event information and questionnaire responses via an online platform. The main outcome is to compare how well the education program with nursing phone follow-up manages these side effects versus conventional treatment alone over one year.

Peripheral T-cell lymphoma (PTCL) includes various mature T-cell lymphoma subtypes, such as angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, which together represent a significant portion of mature T- and NK/T-cell lymphomas. These lymphomas generally have a poor prognosis compared to B-cell lymphomas, with a 10-year survival rate around 30% except for some specific subtypes. Because these diseases are rare and varied, there is no clear consensus on first-line treatment, and the role of autologous stem cell transplantation (ASCT) after achieving complete response remains debated. The study evaluates the use of ASCT as a consolidation treatment for PTCL patients who achieve complete metabolic response after chemotherapy. Participants receive chemotherapy every three weeks for six cycles, with evaluations by PET-CT or CT scans performed during and after treatment to assess response. Patients who achieve complete response after chemotherapy may receive high-dose therapy followed by ASCT. Those not undergoing ASCT will have follow-up evaluations. Both groups undergo multiple scans to monitor disease status. Participants will undergo scheduled assessments including imaging scans to evaluate disease progression or remission. Researchers will track progression-free survival, defined by events such as disease progression, relapse, new lymphoma treatment, or death, over a two-year follow-up period or until 154 such events occur. Safety and effectiveness of ASCT compared to chemotherapy alone will be monitored throughout the study. Participants are expected to comply with visit schedules and study procedures during the entire follow-up period.